Apyx Medical submits FDA 510(k) for AYON Body Contouring System, an innovative solution for comprehensive fat removal and skin tightening.
Quiver AI Summary
Apyx® Medical Corporation has announced the submission of a 510(k) premarket notification to the FDA for its AYON Body Contouring System, designed as a comprehensive solution for body contouring procedures. The system integrates several advanced technologies, including infiltration, dual aspiration, ultrasound-assisted liposuction, and Renuvion treatment for skin tightening. This innovative device aims to streamline surgical processes for body contouring by allowing surgeons to perform multiple functions with one system. The company plans to submit an additional notification later in the year to expand AYON's indications to include power-assisted liposuction. Apyx Medical's President and CEO, Charlie Goodwin, highlighted the early submission as a result of the team's hard work, emphasizing the system's potential to distinguish the company in the aesthetic surgical market.
Potential Positives
- Apyx Medical has submitted a 510(k) premarket notification to the FDA for its AYON Body Contouring System, signaling progress in its product development and regulatory strategy.
- The AYON Body Contouring System is designed as an all-in-one solution for comprehensive body contouring, enhancing its appeal to surgeons and potentially increasing market share.
- The announcement was made almost 90 days earlier than expected, showcasing the efficiency and capability of Apyx Medical's research, development, and regulatory teams.
- The Company plans to expand AYON’s indications with an additional 510(k) submission later this year, indicating ongoing innovation and commitment to growth in the aesthetic surgical field.
Potential Negatives
- Potential regulatory risk associated with the FDA's review of the AYON Body Contouring System, as the approval process is uncertain and could delay product availability.
- Emphasis on forward-looking statements may indicate reliance on future successes that are not guaranteed, creating uncertainty for investors.
- Possible issues related to supply chain disruptions or component shortages, which could affect production and delivery timelines for the AYON system.
FAQ
What is the AYON Body Contouring System?
The AYON Body Contouring System is an advanced device for comprehensive body contouring solutions, integrating multiple functions for surgeons.
What unique features does the AYON system offer?
AYON includes dual aspiration, ultrasound-assisted liposuction, electrocoagulation, volume enhancement, and Renuvion treatment for improved aesthetics.
When did Apyx Medical submit the 510(k) notification?
Apyx Medical submitted the 510(k) premarket notification to the FDA for AYON on January 6, 2025, ahead of schedule.
How does AYON improve aesthetic surgery?
AYON enhances aesthetic surgery by providing versatile and innovative solutions that cater to various patient needs from fat removal to skin tightening.
What are the future plans for the AYON system?
The Company plans to expand AYON's indications with an additional 510(k) submission for power-assisted liposuction later this year.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$APYX Insider Trading Activity
$APYX insiders have traded $APYX stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $APYX stock by insiders over the last 6 months:
- MATTHEW C HILL (Chief Financial Officer) purchased 5,336 shares.
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$APYX Hedge Fund Activity
We have seen 11 institutional investors add shares of $APYX stock to their portfolio, and 20 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- KINGSVIEW WEALTH MANAGEMENT, LLC added 93,417 shares (+301.1%) to their portfolio in Q3 2024
- ROYCE & ASSOCIATES LP added 85,267 shares (+3.4%) to their portfolio in Q3 2024
- WEALTH ENHANCEMENT ADVISORY SERVICES, LLC removed 67,148 shares (-42.5%) from their portfolio in Q3 2024
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 61,727 shares (-82.5%) from their portfolio in Q3 2024
- HB WEALTH MANAGEMENT, LLC added 50,000 shares (+inf%) to their portfolio in Q3 2024
- TAYLOR FRIGON CAPITAL MANAGEMENT LLC removed 43,690 shares (-6.8%) from their portfolio in Q3 2024
- SILVERBERG BERNSTEIN CAPITAL MANAGEMENT LLC removed 23,855 shares (-4.0%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
CLEARWATER, Fla., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apyx
®
Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion
®
, is pleased to announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System.
The AYON Body Contouring System was developed with a focus on versatility and innovation. AYON has been designed to be the only device a surgeon needs for comprehensive body contouring solutions. This all-in-one system integrates advanced modalities to perform multiple functions seamlessly, removing unwanted fat, enhancing tissue contraction and addressing the full range of patient needs from contouring to aesthetic enhancement. The initial submission for AYON includes the following:
Infiltration
Dual aspiration to facilitate simultaneous users
Ultrasound-assisted liposuction
Electrocoagulation to support procedures requiring removal of excess tissue
Volume enhancement capabilities
Renuvion treatment to address loose and lax skin
Later this year, the Company plans to expand the indications with an additional 510(k) submission for AYON to include power assisted liposuction.
“We believe the AYON Body Contouring System is a game changer for surgeons, one that will differentiate and further position Apyx Medical as the premier aesthetic surgical company,” said Charlie Goodwin, President, and CEO of Apyx Medical Corporation. “We are pleased to make this announcement almost 90 days earlier than originally expected, a testament to the capabilities of the hard-working research, development, quality and regulatory teams at Apyx Medical.”
About Apyx Medical Corporation
:
Apyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion
®
in the cosmetic surgery market and J-Plasma
®
in the hospital surgical market. Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The effectiveness of Renuvion and J-Plasma are supported by more than 90 clinical documents. The Company also leverages its deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at
www.ApyxMedical.com
.
Cautionary Statement on Forward-Looking Statements
:
Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but not limited to, projections of net revenue, margins, expenses, net earnings, net earnings per share, or other financial items; projections or assumptions concerning the possible receipt by the Company of any regulatory approvals from any government agency or instrumentality including but not limited to the U.S. Food and Drug Administration (the “FDA”), supply chain disruptions, component shortages, manufacturing disruptions or logistics challenges; or macroeconomic or geopolitical matters and the impact of those matters on the Company’s financial performance.
Forward-looking statements and information are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause the Company’s actual results to differ materially and that could impact the Company and the statements contained in this release include but are not limited to risks, uncertainties and assumptions relating to the regulatory environment in which the Company is subject to, including the Company’s ability to gain requisite approvals for its products from the FDA and other governmental and regulatory bodies, both domestically and internationally; sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; changes in general economic, business or demographic conditions or trends; changes in and effects of the geopolitical environment; liabilities and costs which the Company may incur from pending or threatened litigations, claims, disputes or investigations; and other risks that are described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and the Company’s other filings with the Securities and Exchange Commission. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
Investor Relations Contact
:
Jeremy Feffer, Managing Director LifeSci Advisors
OP: 212-915-2568
jfeffer@lifesciadvisors.com
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